Low Cardiac Output Clinical Trial
Official title:
Comparison Study of Non-invasive Measurement of Blood Pressure and Cardiac Output During Stress Echocardiography
The objectives of the clinical trial is to validate hemodynamic parameters (Blood pressure and Cardiac Output) generated by an application coupled with an off-the-shelf pulse oximeter. The validation will be done by comparing the generated information to data gathered while performing Stress Echocardiography. The first phase of the study will be done on 10 patients undergoing a Stress Echocardiography test at the cardiology department at Meir Hospital
The HeartBeat system combines an FDA/CE approved watch-like Pulse Oximeter for acquiring the
data and an android software application that serves as the Hemodynamic calculator. The
application performs POST-PROCESSING of the PhotoPlethismoGraphic (PPG) signal (Normally the
PPG signal in Pulse Oximeters is used only to compute heart rate and SpO2). The raw data is
transferred from the watch oximeter to the smartphone using a standard Bluetooth protocol.
The Post-processing uses wavelet signal processing to estimate and display certain
Hemodynamic parameters like Blood Pressure (BP) and Cardiac Output (CO) in a continuous and
graphical way on a standard Android device. In addition to the standard heart rate and SpO2,
the application displays the measured PPG signal and estimated continues BP and CO.
HeartBeat is the only device that can non-invasively estimate Continuous BP and its Cardiac
Output component and the resistance component in a mobile wearable device. Differentiating
between these 2 components can play a major role in helping the doctor to understand the
effect of cardiovascular medications and Lifestyle interventions.
The trial will compare blood pressure and cardiac output parameters measured during Stress
Echocardiography using an echo cardiograph and standard sphygmomanometer to the parameters
generated by the application.
Trial goals
- Feasibility tests for the HeartBeat application as a tool for monitoring BP and CO
changes over time
- Compare BP and CO parameters generated by the applications to the ones measured by
standard non-invasive equipment during a Stress Echocardiography
- Calculate additional parameters such as stroke volume, systematic vascular resistance
and cardiac index
;
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